The Inspection Readiness Lead provides crucial TMF oversight in collaboration with QA to ensure Inspection Readiness for TMF Portfolio.
Required Skills & Experience
- Collaborate with current TMF Advisor on process improvement and TMF-Quality Oversight
- Liaise with relevant functional leaders regarding responses to audits, inspections and CAPA management associated to TMFs and the management process
- Support inspections and audits, including preparedness and being a point of contact for TMF related questions across the portfolio
- Ensure eTMF specifications for the project are compliant and consistent with program strategy, company standards, and applicable regulatory requirements and guidance
- Provide guidance, clarification, and strategy for regulatory requirements and compliance
- Support study team in addressing/reporting regulatory queries pertaining to document management.
- Conducts gap analysis and develops plans to address deficiencies, may facilitate implementation of plan as well
- Advises on industry trends and regulatory changes that may affect TMF management,
- Designs and develops training, SOPs, and other guidance documents needed to support management of TMF activities
- Process & Compliance
- Workstream support
- Logistics and meeting that support study team deliverables for Inspections
- Collaboration with TMF team for IR support activities
Working Hours – 8am – 4pm EST
- Minimum 5 years of relevant experience in Clinical or TMF Operations oversight
- Experience working with QA department
- Experience in regulatory agency inspections
- Demonstrated awareness of sponsor oversight and TMF
- Experience in management of medical/clinical study records and documentation.
- Experience/knowledge of ICH/GCP documentation requirements.
- Clinical Documentation Management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
- Experience with the following application types: Electronic documentation management systems, web-based data management systems, as required, and database utilization
- Outstanding verbal and written communications skills, combined with outstanding listening skills are required.
- History of achievement in a customer service role with demonstration of meeting customer needs and concerns.
- History of achievement in building strong customer relationships. Strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in high-stress situations is very important.
- Strong background in provision of high levels of Customer Service evidenced by positive feedback from customers
Travel Requirements - Ability to travel domestically within U.S. on average up to 10%
Why Work for Phlexglobal?
We offer challenging careers, projects, great benefits and a comprehensive and competitive rewards package, including great training and personalized career development opportunities.
Our benefits typically include a competitive base salary and generous annual leave. We also provide 401k, medical, dental and vision insurance.